Global Study Looking at the Combination of RAD001 and Sorafenib to Treat Patients With Advanced Hepatocellular Carcinoma

This study has been terminated.

Sponsor:

Novartis Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00828594

First Posted: January 26, 2009

Last Update Posted: April 11, 2013

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Phase 1 Evaluate the safety and tolerability of RAD001 in combination with sorafenib in patients with advance hepatocellular cancer (HCC) and to determine the maximum tolerated dose (MTD)

Phase 2 To estimate the treatment effect as a measure of anti-tumor activity in terms of Time to Progression (TTP) of the combination of RAD001 plus sorafenib, at the MTD, as compared to sorafenib alone

Time to disease progression assessed when 60 events have been observed [ Time Frame: Until number of events are reached ]

Secondary Outcome Measures:

Safety and tolerability of the combination of RAD001 plus sorafenib as measured by the rate and severity of adverse events [ Time Frame: Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity ]

Tumor response [ Time Frame: Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity ]

Biomarkers- effect of treatment on soluble markers of angiogenesis and apoptosis [ Time Frame: Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity ]

Overall tumor response (phase 2) [ Time Frame: Estimate of 1 year for each patient - Until number of events reached and final analysis ]

Progression Free Survivor, Overall Survivor (phase 2) [ Time Frame: Estimate of 1 year for each patient - Until number of events reached and final analysis ]

Safety and tolerability - of the combination of RAD001 plus sorafenib as measured by the rate and severity of adverse events (phase 2) [ Time Frame: Estimate of 1 year for each patient - Until number of events reached and final analysis ]

Pharmokinetics of RAD001 at pre-dose and 1 hour and 2 hours post-dose (phase 2) [ Time Frame: Estimate of 1 year for each patient - Until number of events reached and final analysis ]

Biomarkers effect of treatment on soluble markers of angiogenesis and apoptosis (phase 2) [ Time Frame: Estimate of 1 year for each patient - Until number of events reached and final analysis ]

Pharmokinetics of RAD001 at pre-dose and 1 hour and 2 hours post-dose [ Time Frame: Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity ]

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Advanced liver cancer

No previous systemic therapy for liver cancer

Measurable disease on CT or MRI

ECOG 1 or less

Child-Pugh A

Exclusion Criteria:

Active bleeding during the last 30 days

Known history of HIV seropositivity

Any severe and/or uncontrolled medical conditions including

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00828594